Through comprehensive pre-formulation studies on the candidate injectable product, we design formulations and processes that are consistent with target product profile. We have experience in the development of insoluble, complex, and unique injectable products – for vials, pre-filled syringes, ampules, and blow-fill-seal formats.

Formulation Development Capabilities

  • Lyophilized vials/bulk trays
  • Emulsions, Liposomes, and Micro- and nano-suspensions
  • Ophthalmic emulsion and ophthalmic suspension products
  • Injectable microspheres
  • Potent, Oncology injectable products

Late-stage Product Development Support

  • Technology Transfer for Scale-up/Transfer to Commercial Manufacturing Site
  • QbD and Validations 
  • Preparation of development summaries in e-CTD formats
  • Complete regulatory support for US and other markets